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High-Dose Pharmacotherapy with VAD in Heart Failure
NCT00402376Phase 4
Key facts
- Status
- Terminated
- Start
- Apr 2007
- Countries
- 1
- Sponsor
- Strasbourg University Hospital
- Modality
- Small Molecules
- Drugs
- pravastatin
- Conditions
- heart failure (HF)
01
Overview
Phase 4, randomised, single-blind trial of pravastatin in heart failure (HF) (2 arms), sponsored by Strasbourg University Hospital. Primary endpoint: Mitochondrial respiratory function. Started Apr 2007; status: terminated.
02
Design
2 arms- Study design
- RandomizedSingle-blind
High Dose Pharmacotherapy
High doses of Pravastatin, Carvedilol, Perindopril + VAD support
Standard Dose Pharmacotherapy
Standard doses of Pravastatin, Carvedilol, Perindopril + VAD support
03
Who it enrols
Patients with end-stage heart failure refractory to medical therapy who fulfill criteria for VAD implantation as a bridge to heart transplantation.
04
Endpoints
Primary
Mitochondrial respiratory function
Secondary
Inflammation: IL-6; IL-8; IL-10, IL-18, TNF-alpha
Exercise testing: stress echocardiography, peak oxygen consumption
Hormonal cardiac function: ANP, BNP
Ventricular remodelling: echocardiography
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